(74 days)
The Dukal medical / surgical masks are indicated as a protective nose and mouth covering for healthcare workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situation where there is a risk of microorganism, body fluid and particulate aerosol transfer.
Dukal Surgical Masks are pleated 3 – ply masks. Inner and outer layers are made of either medical grade tissue or 100% spun-bond polypropylene. Middle layer is made of 100% melt blown polypropylene filter. Ear loops are made of soft latex free elastic loops. The nose piece for all Dukal Masks is a malleable aluminum wire. Masks with splash visors have an anti fog treated plastic shield attached to masks. All of the material used in the construction of the Dukal face masks are being used in currently marketed devices (see predicate information)
Here's a breakdown of the acceptance criteria and study information for the Dukal Surgical Mask, based on the provided 510(k) summary:
This device is a surgical mask, and the study described is a performance characteristic comparison against a predicate device and recognized standards, rather than a clinical study involving human readers or AI. Therefore, several sections of your request (MRMC study, standalone performance, training set details) are not applicable.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the performance of the predicate device and the specified ASTM standards. The reported device performance is compared directly to these.
| Item | Acceptance Criteria (Predicate: Medicom K051291) | Reported Device Performance (Dukal Surgical Mask) | Test Method |
|---|---|---|---|
| Functional Properties | |||
| Inner Layer Raw Material | 100% Spun-bond polypropylene or medical grade tissue | 100% Spun-bond polypropylene or medical grade tissue | Raw material Specifications |
| Outer Layer Raw Material | 100% Spun-bond polypropylene or medical grade tissue (14gsm) | 100% Spun-bond polypropylene or medical grade tissue (16gsm) | Raw material Specifications |
| Middle Layer Raw Material | 100% melt blown polypropylene filter media | 100% melt blown polypropylene filter media | Raw material Specifications |
| Ear Loop Raw Material | Latex Free Elastic Loops and ties (38 gsm) | Soft latex free elastic loops and ties (40 gsm) | Raw material Specifications |
| Nose Piece Raw Material | Malleable aluminum wire | Malleable aluminum wire | Raw material Specifications |
| Plastic Shield Raw Material | ATFF-High Impact 0.10mm | ATFF-High Impact 0.10mm | Raw material Specifications |
| Mask Styles | Tie, Ear Loop and mask with fluid shield | Tie, Ear Loop and mask with fluid shield | N/A |
| Color | Blue | Blue | N/A |
| Layers | 3 | 3 | N/A |
| Performance Criteria | |||
| Fluid Resistance Performance (mmHg) | Pressure at 80mmHg, 19 out of 32 passed | 30 out of 32 passed | ASTM F1862-05 |
| Particulate Filtration Efficiency Performance (%) | 98.7% | 98.3% | ASTM2299 |
| Bacterial Filtration Efficiency Performance (%) | 99.8% | 99.9% | ASTM F2101-01, ASTM F2100-04 |
| Differential Pressure (Delta-P) (mmH2O/cm²) | 2.28 (ave) mmH2O/cm² | 2.28 (ave) mmH2O/cm² | ASTM F2101-01, MIL-M-36945C 4.4.1.1.1 Method 1 |
| Flammability class 1 | No Flame Spread Class 1 | No Flame Spread Class 1 | ASTM F2101-01, MIL-M-36945C 4.4.1.1.1 Method 1 |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set:
- For the Fluid Resistance Performance test (ASTM F1862-05), the sample size was 32 units tested for both the predicate device and the Dukal mask.
- For other performance tests like Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, and Flammability, a specific sample size is not explicitly stated in the provided text, but it is implied that sufficient samples were tested to obtain the reported percentages and average values according to the specified ASTM standards.
- Data Provenance: Not specified, but implied to be from laboratory testing conducted by Dukal Corporation for their device and likely from the predicate device's 510(k) submission for its data. This is a retrospective comparison against listed predicate device performance and standards. The country of origin of the testing is not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This study involves objective performance testing of a physical product (surgical mask) against defined material specifications and ASTM standards, not the interpretation of medical data by experts. The "ground truth" for each parameter is established by the results of the standardized test methods.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this involves objective physical testing, not expert interpretation requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
Not applicable. This is not an AI/software device and no MRMC study was performed.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
Not applicable. This is not an AI/software device. The device's performance is standalone in the sense that its physical properties are measured directly.
7. The Type of Ground Truth Used
The ground truth for the performance characteristics is established by:
- Recognized Performance Standards: Specifically, ASTM F1862-05, ASTM2299, ASTM F2101-01, ASTM F2100-04, and MIL-M-36945C. These standards define the acceptable methodology and often performance benchmarks.
- Predicate Device Performance: The performance data of the legally marketed predicate device (A.R. Medicom K051291) serves as a benchmark for substantial equivalence.
- Raw Material Specifications: For the composition of the mask layers, ear loops, nose piece, and plastic shield.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set was used.
§ 878.4040 Surgical apparel.
(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.